NA 212.812Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982152824), received between Oct 3, 2019 and Oct 3, 2019 — classified as 3 injuries.

11 other recalls cover devices cleared under the same FDA submission (K012114, K040588, K050110, K063049, K102694, K103243); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2019, A MINI FRAG SET WAS DISCOVERED OF HAVING A 12MM 2.4MM CORTEX SCREWS IN THE SLOTS WHERE 12MM 2.4MM LOCKING SCREWS SHOULD BE. IT WAS MENTIONED THAT THE SURGEON WANTED A 12MM LOCKING SCREWS BUT HAD TO USE SOMETHING ELSE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY REPORTED. PATIENT CONDITION WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 2.4MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 12MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9153339 ↗
• InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2019, A MINI FRAG SET WAS DISCOVERED OF HAVING A 12MM 2.4MM CORTEX SCREWS IN THE SLOTS WHERE 12MM 2.4MM LOCKING SCREWS SHOULD BE. IT WAS MENTIONED THAT THE SURGEON WANTED A 12MM LOCKING SCREWS BUT HAD TO USE SOMETHING ELSE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY REPORTED. PATIENT CONDITION WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN) THIS REPORT IS FOR ONE (1) 2.4MM LOCKING SCREW SLF-TPNG WITH STARDRIVE RECESS 12MM THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9153288 ↗
• InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2019, A MINI FRAG SET WAS DISCOVERED OF HAVING A 12 MM 2.4 MM CORTEX SCREWS IN THE SLOTS WHERE 12 MM 2.4 MM LOCKING SCREWS SHOULD BE. THE SET WAS DELIVERED FROM FIELD STOCKING LOCATION (FSL). IT WAS MENTIONED THAT THE SURGEON WANTED A 12 MM LOCKING SCREWS BUT HAD TO USE SOMETHING ELSE TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO SURGICAL DELAY REPORTED. PATIENT CONDITION WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 2.4 MM LOCKING SCREW SLF-TPNG WITH STAR DRIVE RECESS 12 MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9153273 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K012114, K040588, K050110, K063049, K102694, K103243. One submission often covers many models, so check the product and lot details in each record.

• Z-0883-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0880-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0882-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0879-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0881-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag
• Z-0167-2016 · Oct 6, 2015 · Terminated
  2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantati
• Z-0380-2014 · Jul 31, 2013 · Terminated
  2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragmen
• Z-0956-2013 · Jan 11, 2013 · Terminated
  Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Cor
• Z-0489-2007 · Dec 5, 2006 · Terminated
  LCP Volar Distal Radius Plate Extra Articular 4H HD-RT-Long, LCP Volar Distal Radius Plate 2.4 mm, Catalog number 242.465